MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Device Operates Differently Than Expected (2913); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2012

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that the patient was confused about terms and it was not clear whether the patient was referring to the ins or patient programmer.The patient reported they had 2 stimulators, meaning programmers, because the first one did not work right and they had sent them another one.They were both the same model, but had different numbers on the back.Patient was calling to make sure they were using the correct one.It was reviewed she could use either programmer and not break anything.Patient was asked to explain what did not work right with their first one and they stated they had all kinds of trouble getting it implanted.They stated your equipment did not work at all and they had to call the patient back and start all over again.It took a long time to even get one implanted.Since then they had ended up with 2 programmers.When asked to clarify which equipment didn't work the patient stated the first time they went in for surgery they put the whole thing in and nothing happened.When the patient got home, they got a call stating it was not them, it was the problem with the equipment.They then started over again.They further explained that on the day of implant there was something wrong with the piece of equipment they were using, patient guessed it was the implant.It took about 1.5 years to finally get one working.Patient was asked if they replaced the ins or the patient programmer, patient stated they still had it, meaning the patient programmer.It was replaced in 2014.When asked again which was not working, the patient stated the programmer.At the implant surgery, their healthcare provider told them they could start over.No patient symptoms were reported.No further complications were reported or anticipated.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7493795
• MDR Text Key: 107568234
• Report Number: 3004209178-2018-10327
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• Date Device Manufactured: 09/05/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR